Sr. Director Clinical Quality Assurance
2 weeks ago
Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.
Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease.At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone's health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.
The Senior Director, Clinical Quality Assurance is responsible for end-to-end Clinical Quality Assurance with an emphasis on radiotherapeutic and diagnostic products. The Senior Director, Clinical Quality Assurance will be responsible for the oversight of all clinical trial performed by the company including international clinical trials, Early Access Programs, Investigational Sponsored Trials and Collaboration studies. This role will oversee all clinical operation activities and third-party qualifications, inspection readiness program, quality plans, policies and quality system elements related to clinical quality activities in support of clinical programs. The Senior Director, Clinical Quality Assurance will establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance in an international regulatory environment and provide guidance in clinical Quality related areas.
Key Responsibilities/Essential Function
- Responsible for leading the Clinical Quality Assurance team to oversee all clinical trials performed or directed by the company.
- Manage the CQA activities including third party, quality plans and internal auditing, risk management and day to day clinical study team support.
- Liaise across Clinical, Medical, Regulatory and R&D departments to proactively identify opportunities to streamline and strengthen clinical Quality process.
- Reviews study team and regulatory documentation as requested (e.g., Data Management, Operations, Safety, Regulatory, etc.).
- Support the reviews and approves of internal and external audit reports, Quality Events (deviations) and associated Corrective and Preventative Actions within a regulated Quality Management System.
- Represents Clinical Quality expertise across the company with GCLP and GCP including ex-US experience. .
- Keeps current with global health authority laws and regulations; identifies gaps and implements process improvements resulting from new/revised regulations or guidance.
- Leads external Health Authority inspections and internal audits.
- Provides guidance in global regulatory reporting requirements (e.g. serious breach, etc).
- Establishes a global inspection readiness program.
- Bachelor's degree with 15 or more years' experience working in clinical development, preferably in either a clinical compliance or clinical Quality Assurance.
- Must be strategic as well as a hands-on leader who can see "the big picture" while providing guidance to execute daily tasks
- Experience in managing a team of CQA professionals
- Demonstrated Quality Management System experience appropriate for the clinical development including EAP, IST and Collaboration Studies.
- Demonstrated understanding in third party/internal Quality audits, Issue Management and CAPA in a clinical environment.
- Experience leading FDA or other Health Authority Inspections
- Strong knowledge of global clinical trial regulations (e.g. ICH, FDA, etc) and guidelines, particularly in GCLP, and GCP
- Proficient in risk management principles
- Self-motivated with the ability to work effectively in a dynamic environment.
- Strong leadership with demonstrated ability to interface with senior leaders and different levels of the organization to provide solutions to complex situations.
- Excellent critical thinking and problem-solving skills and strong collaborator.
- Ability to effectively manage multiple priorities with a sense of urgency.
- Strong track record of project management, stakeholder management, collaboration skills and negotiation of complex situations.
- Attention to detail and accuracy of work.
- Demonstrated ability to work well with other accomplished professionals within and across functions/teams.
- Strong communication skills both written and oral.
- Routine and, or overnight travel required based on business need.
#LI-REMOTE
-
Sr. Associate, Quality Assurance
5 days ago
Bedford, United States GQR Full timeTitle: Sr. Associate, Quality Assurance Status: contract through end of year Location: Onsite, Bedford, MA Hourly rate: $60As a Senior Specialist, Quality Assurance (Warehouse Operations) you will be responsible for QA support of the warehouse and supply chain processes at the new gene therapy manufacturing facility located in Bedford, MA. The site is a...
-
Sr. Associate, Quality Assurance
5 days ago
Bedford, United States GQR Full timeTitle: Sr. Associate, Quality Assurance Status: contract through end of year Location: Onsite, Bedford, MA Hourly rate: $60 As a Senior Specialist, Quality Assurance (Warehouse Operations) you will be responsible for QA support of the warehouse and supply chain processes at the new gene therapy manufacturing facility located in Bedford, MA. The site is a...
-
Sr. Associate, Quality Assurance
4 days ago
Bedford, United States GQR Full timeTitle: Sr. Associate, Quality Assurance Status: contract through end of year Location: Onsite, Bedford, MA Hourly rate: $60 As a Senior Specialist, Quality Assurance (Warehouse Operations) you will be responsible for QA support of the warehouse and supply chain processes at the new gene therapy manufacturing facility located in Bedford, MA. The site is a...
-
Manager, Clinical Quality Assurance
4 days ago
Bedford, United States Lantheus Full timeLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing organization that provides...
-
Manager, Clinical Quality Assurance
3 days ago
Bedford, United States Lantheus Medical Imaging Inc Full timeJob DescriptionJob DescriptionLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing...
-
Manager, Clinical Quality Assurance
4 days ago
Bedford, United States Lantheus Full timeLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.Lantheus is an entrepreneurial, agile, growing organization that provides...
-
Pharmaceutical Quality Assurance Specialist
4 weeks ago
Bedford Park, United States Ingredion Incorporated Full timeAs a Pharmaceutical Quality Assurance Specialist, API your responsibilities will include:Perform batch record review on all API and NF batches. Monitor the day-to-day quality activities of the API to produce and package products of sufficient quality Quality Assurance, Assurance, Pharmaceutical, Specialist, Quality, Operations, Manufacturing, Technology
-
Hospice Director of Clinical Services
4 days ago
Bedford, United States Compassus Full timeAt Compassus, we know that caring for our teammates is the first step in caring for our patients. We are committed to providing Care for Who You Are and What You Need to balance work and life including flexible scheduling, a supportive family-focused culture and first-class compensation and benefits. Your position perks as a Hospice Director Clinical...
-
RN Sr-Clinical Research
5 days ago
Bedford, United States US Oncology, Inc Full timeRN Sr-Clinical ResearchOverview Texas Oncology is looking for a Full-time Clinical Research Nurse (RN) to join our team! This position will support the Bedford location. This is a Full-time Monday-Friday 8:30am-5pm position with no weekends, call, or major holidays. Texas Oncology is the largest community oncology provider in the...
-
Pharmaceutical Quality Assurance Specialist
5 days ago
Bedford Park, United States Ingredion Inc, Full timeAs a Pharmaceutical Quality Assurance Specialist, API your responsibilities will include: * Perform batch record review on all API and NF batches. * Monitor the day-to-day quality activities of the API to produce and package products of sufficient quality and quantity that meet the requirements of customers and regulatory bodies. * Assist in deviation...
-
Director, Clinical Science
4 weeks ago
Bedford, United States Lantheus Holdings, Inc. Full timeLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and have helped physicians enhance patient care with our broad product portfolio. Lantheus is an entrepreneurial, agile, growing organization that provides...
-
Director, Clinical Science
1 month ago
Bedford, United States Progenics Pharmaceutical Inc Full timeJob DescriptionJob DescriptionLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and have helped physicians enhance patient care with our broad product portfolio. Lantheus is an entrepreneurial, agile, growing...
-
Head of Quality Operations
4 days ago
Bedford, United States Obsidian Therapeutics Full timeHead of Quality Operations Bedford, MA About Us… Obsidian Therapeutics is expanding the reach of TIL therapy. We are pioneering engineered tumor infiltrating lymphocyte (TIL) therapies to deliver transformative outcomes for patients suffering from solid tumor malignancies. Obsidian’s programs apply our cytoDRiVE® platform technology to express...
-
RN Sr-Clinical Research
5 days ago
Bedford, TX, United States US Oncology, Inc Full timeRN Sr-Clinical Research Overview Texas Oncology is looking for a Full-time Clinical Research Nurse (RN) to join our team! This position will support the Bedford location. This is a Full-time Monday-Friday 8:30am-5pm position with no weekends, call, or major holidays. Texas Oncology is the largest community oncology provider in the...
-
Associate Director, Clinical Operations
1 week ago
Bedford, United States Progenics Pharmaceutical Inc Full timeJob DescriptionJob DescriptionLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing...
-
Bedford, United States Chick-fil-A Supply LLC Full timeOverview: As the Safety, Quality & Compliance (SQC) Sr. Specialist, you will lead the application of regulatory compliance in multiple areas, including food safety quality assurance (FSQA) and environmental, health and safety (EHS). In addition, you will lead the execution of risk management, contingency planning, safety and training at the Chick-fil-A...
-
Medical Director, Clinical Research
2 weeks ago
Bedford, United States Lantheus Full timeDescription Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing organization that...
-
Medical Director, Clinical Research
1 week ago
Bedford, United States Lantheus Holdings, Inc. Full timeLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing organization that provides...
-
Medical Director, Clinical Research
3 weeks ago
Bedford, United States Lantheus Full timeDescription Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing organization that...
-
Medical Director, Clinical Research
3 weeks ago
Bedford, United States Lantheus Medical Imaging Inc Full timeJob DescriptionJob DescriptionLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing...
